FlexForm Annuloplasty Ring

GUDID B040FRH26

Annuloplasty Ring

GENESEE BIOMEDICAL, INC.

Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring

• Primary Device ID: B040FRH26
• NIH Device Record Key: b981ab7f-c664-435a-98d8-98571d93c9a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexForm Annuloplasty Ring
• Version Model Number: FRH-26
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040FRH26 [Package]; Contains: B040FRH260; Package: [1 Units]; In Commercial Distribution
HIBCC	B040FRH260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161815

FDA Product Code

• KRH: Ring, Annuloplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-01

On-Brand Devices [FlexForm Annuloplasty Ring]

• B040FRN40: Annuloplasty Ring
• B040FRN38: Annuloplasty Ring
• B040FRN36: Annuloplasty Ring
• B0040FRN34: Annuloplasty Ring
• B040FRN32: Annuloplasty Ring
• B040FRN30: Annuloplasty Ring
• B040FRN28: Annuloplasty Ring
• B040FRN26: Annuloplasty Ring
• B040FRN240: Annuloplasty Ring
• B040FRH40: Annuloplasty Ring
• B040FRH38: Annuloplasty Ring
• B040FRH36: Annuloplasty Ring
• B040FRH34: Annuloplasty Ring
• B040FRH32: Annuloplasty Ring
• B040FRH30: Annuloplasty Ring
• B040FRH28: Annuloplasty Ring
• B040FRH26: Annuloplasty Ring
• B040FRH24: Annuloplasty Ring